Ignite Creation Date:
2025-12-25 @ 1:30 AM
Ignite Modification Date:
2026-01-03 @ 11:55 AM
Study NCT ID:
NCT02029794
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2014-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ASPIRE Pilot: Comparing Self-collected HPV Testing With Visual Inspection With Acetic Acid Screening for Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}, {'id': 'D019342', 'term': 'Acetic Acid'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-01', 'studyFirstSubmitDate': '2014-01-02', 'studyFirstSubmitQcDate': '2014-01-07', 'lastUpdatePostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histologically confirmed cervical intra-epithelial lesions grade 2 (CIN2) or greater in self-collected HPV arm and VIA arm at 12 months by colposcopy', 'timeFrame': 'At the 12 month follow-up visit', 'description': 'Presence of low grade (CIN1) or moderate to high grade lesions (CIN2 or greater) will be compared between the two groups using chi-square testing at month 12.'}], 'secondaryOutcomes': [{'measure': 'Uptake of HPV self-collection compared to VIA in women in Kampala, Uganda', 'timeFrame': 'One Year', 'description': "Proportion of women who provide HPV self collected specimen or who attend initial VIA will be compared between groups using Pearson's Chi-square test. Proportion of women who complete all recommended follow-up assessments and treatment (if required) will be compared between groups using chi-square testing."}, {'measure': 'Prevalence rates of high-risk HPV in the self-collection arm.', 'timeFrame': 'One year'}, {'measure': 'Assess screen positive rates by nurse-midwife exam in VIA arm', 'timeFrame': 'One year'}, {'measure': 'Evaluation of adverse events or complications documented at time of sample collection, 4-6 weeks after cryotherapy and at 12 and 36 months by study questionnaire', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cervical Cancer', 'Cervical Cancer Screening', 'Low Resource setting', 'HPV', 'Self-Collection', 'VIA'], 'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'Cervical cancer remains a public health burden, particularly in developing countries such as sub-saharan Africa where the infrastructure for organized screening programs does not exist. As a result, other screening modalities (visual inspection with acetic acid) are the standard of care in such regions. It is now known, persistent infection with an oncogenic Human papillomavirus (HPV) type is a necessary precursor of cervical cancer and evidence is showing HPV testing is a potential, safe and effective alternative to cytology testing (The Pap smear). This study is evaluating the feasibility and acceptance of HPV self-collection vs. VIA in a cohort of women from Kisenyi, Uganda.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 30-65yrs\n* Living or working in community of Kisenyi, Uganda\n* Access to mobile telephone\n* Fluent in Luganda, Somali or English\n* Competent to provide informed consent\n\nExclusion Criteria:\n\n* Known to be pregnant at study entry (self-reported)\n* Complete hysterectomy\n* Prior diagnosis or treatment of cervical dysplasia or cervical cancer'}, 'identificationModule': {'nctId': 'NCT02029794', 'acronym': 'ASPIRE', 'briefTitle': 'ASPIRE Pilot: Comparing Self-collected HPV Testing With Visual Inspection With Acetic Acid Screening for Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'ASPIRE Pilot: Determining Optimal Cervical Cancer Screening in a Low-resource Setting: A Randomized Controlled Trial Comparing Self-collected HPV Testing With Visual Inspection With Acetic Acid (VIA) Screening in Kampala, Uganda', 'orgStudyIdInfo': {'id': 'H13-02627'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HPV Self-collection', 'description': 'Subjects will self-collect a cervical-vaginal sample. One time use.', 'interventionNames': ['Procedure: HPV self-colleciton']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VIA arm', 'description': 'Standard of care in Uganda is visual inspection with acetic acid (VIA). Women randomized to this arm will undergo the following: Cervix examined by clinician using speculum and light source. Cervix then sprayed with 3-5% acetic acid, and then lesions described one minute after application of acetic acid. VIA negative no acetowhite lesions detected; positive is when dense aceto-white lesions are seen touching squamocolumnar junction', 'interventionNames': ['Procedure: visual inspection with acetic acid (VIA)', 'Drug: 3-5% acetic acid']}], 'interventions': [{'name': 'HPV self-colleciton', 'type': 'PROCEDURE', 'otherNames': ['Women will self-collect a cervical-vaginal specimen per instructions. Sample will then receive high-risk HPV DNA testing.'], 'description': 'Women will self-collect a cervical sample that will be provided to an outreach worker and then labelled and sent to laboratories in Kampala for HPV testing. Women who test positive for HPV will be contacted by phone and provided with follow-up instructions.', 'armGroupLabels': ['HPV Self-collection']}, {'name': 'visual inspection with acetic acid (VIA)', 'type': 'PROCEDURE', 'otherNames': ['VIA conducted per standard of care.'], 'armGroupLabels': ['VIA arm']}, {'name': '3-5% acetic acid', 'type': 'DRUG', 'armGroupLabels': ['VIA arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University of British Columbia', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Gina Ogilvie, MD FCFP DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Makerere University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Gina Ogilvie', 'investigatorFullName': 'Gina Ogilvie', 'investigatorAffiliation': 'University of British Columbia'}}}}